Scribd
Upload
66 views3 pages

Pharma Grade Ethanol 96% Specifications

The document provides detailed specifications and safety information for Ethanol 96% v/v (pharma grade), including its chemical properties, physical data, and transport regulations. It outlines various tests for purity and impurities, as well as hazard classifications and handling precautions. Additionally, it includes references to pharmacopoeias and regulatory compliance for the product.

Uploaded by

blancaoscura0
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
66 views3 pages

Pharma Grade Ethanol 96% Specifications

The document provides detailed specifications and safety information for Ethanol 96% v/v (pharma grade), including its chemical properties, physical data, and transport regulations. It outlines various tests for purity and impurities, as well as hazard classifications and handling precautions. Additionally, it includes references to pharmacopoeias and regulatory compliance for the product.

Uploaded by

blancaoscura0
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Ed.: 26 . Vig.: 10.06.2021 . Prod.

: 141085

PRODUCT CODE: 141085

Ethanol 96% v/v (USP, BP, [Link].) pure, pharma grade

C2H6O
CH3CH2OH

M.= 46,07 CAS [64-17-5] EINECS 200-578-6


TARIC 2207 10 00 90

SYNONYMS: Ethyl Alcohol


PHYSICAL DATA: liquid, Clear, Colourless, Miscible with water and most of the solvents • D 20/4 0,805 • M.P.: -
114,1 °C • B.P.: 78,5 °C • n20/D : 1,361 • Flash P.:14 °C • Ign. T.:~425 °C • Vap. press. (20 °C) 57,26 hPa •
Viscosity 1,2 mPa.s • Expl. limit2,5 %(V)13,5 %(V) •
BIBLIOGRAPHY: Merck Index 12, 3.806 13, 3.795 Sax EFU300 • Ullmann (5.)9 , 587 • Beilstein 1 , IV , 1289 • BRN
1718733 • ACS XI • BP.2021 • USP 42 • Ph. Eur. 9.0 (2017) 10.0 (2020) • F.C.C 11 12 • Directive
88/344/E.C.E.92/115/E.C.E.94/52/EC97/60/EC (27/10/1997) 2009/32/CE • DAB 10, Royal Decree 472/1990
(6/4/1990) , 2667/1998 (11 /12/1998), 1101/2011 (22/7/2011), F. U. IX , 74, Ph.F. X , 15 •

HAZARDOUS: C.E: 603-002-00-5 • RTECS: KQ 6300000 • LD50 oral rat 6.200 - 15.000 mg/kg / (OECD 401) • LC50
rat >50mg/m3 / (OECD 403) • VLA-ED 1.000 ppm1.920 mg/m3

H: H225 • H319 •
P: P210 • P233 • P240 • P241 • P242 • P501 • P243 • P280 • P303+P361+P353 • P370+P378 • P403+P235 • P264 •
P305+P351+P338 • P337+P313 •

TRANSPORT REGULATIONS: UN: 1170 • ADR: 3/II • IMDG: 3/II • IATA: 3/II • PAX: 353 • CAO: 364 • (D/E) •
WEIGHT/VOLUME INFORMATION: 1l~0,805 kg 1kg~1,242 l
OBSERVATIONS: May be subject to special tax. • Storage away from direct light, away from sources of ignition and
heat. Storage at temperature below 25ºC. •

SPECIFICATIONS:
Assay (G.C.) (v/v) 96,0-96,6 %
Identity :
Identity according to Pharmacopoeias: passes test
Density at 20/20 0,8051-0,8124

Maximum limit of impurities


ABS
at λ 240 nm 0,40
at λ 250-260 nm 0,30
at λ 270-340 nm 0,10
Absorption curve,smooth at λ passes test
Appearance passes test
Acidity or alkalinity passes test
Alkalinity 0,001 meq/g
Insoluble matter in H2O passes test
Non-volatile matter (w/v) 0,0025 %
Reducing substance to KMnO4 passes test
Clarity of solution passes test
Fusel oil passes test
Residual solvents ([Link]/USP) passes test
Benzene (U.V.) 0,0002%
Aldehydes (as CH3CHO) 0,001%
Acetone (G.C.) 0,005%
Butanone (G.C.) 0,02%
2-Propanol (G.C.) 0,03%
1-Pentanol, non-volatile subst. and carbonized subst. passes test
by H2SO4
Acetone, 2-Propanol and 2-Methyl-2-Propanol passes test
Volatile impurities (G.C.)
Methanol 0,02%
Acetaldehyde and acetal 0,001 %
Benzene 0,0002 %
Total other impurities 0,03 %

Fe 0,00005 %

Elemental impurities (ICH Q3D):

Class 1
Cd 0,5 ppm
Pb 0,5 ppm
As 1,5 ppm
Hg 1,5 ppm

Class 2A
Co 5 ppm
V 10 ppm
Ni 20 ppm

Class 2B
Tl 0,8 ppm
Au 10 ppm
Pd 10 ppm
Ir 10 ppm
Os 10 ppm
Rh 10 ppm
Ru 10 ppm
Se 15 ppm
Ag 15 ppm
Pt 10 ppm
Class 3
Li 55 ppm
Sb 120 ppm
Ba 140 ppm
Mo 25 ppm
Cu 250 ppm
Sn 600 ppm
Cr 25 ppm

Ed.: 26 . Vig.: 10.06.2021 . Prod.: 141085

You might also like